Apparatus and method for preventing free flow in an infusion line

ABSTRACT

An apparatus and method for preventing free flow through an infusion set utilizes an occluder disposed within the infusion set to selectively prevent flow therethrough. The occluder may be responsive to a pressure differential within the infusion set or may respond to compression of the infusion set. When a pair of occluders are used in sequence, an in-line pump may be formed.

RELATED APPLICATIONS

The present application is a continuation-in-part of U.S. patentapplication Ser. No. 09/836,850, filed Apr. 16, 2001, which is acontinuation-in-part of U.S. patent application Ser. No. 09/569,332,filed May 11, 2000 now U.S. Pat. No. 6,595,950.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates to an apparatus and method for preventingfree flow during enteral or parenteral administration solutions throughan infusion line. More particularly, the present invention relates to anoccluder/valve and method of use for infusion sets and the like, whereinthe occluder/valve prevents undesirable free-flow of solution throughthe infusion set while allowing controlled flow through the infusionset.

2. State of the Art

The use of infusion sets to administer solutions to patients is wellknown in the medical arts. Infusion sets are used for both enteral andparenteral applications. Enteral feeding pumps are used to providepatients with nutrition and medication when they are unable, for avariety of reasons, to eat normally. Parenteral (intravenous) solutionsare provided to patients to ensure adequate hydration and to provideneeded nutrients, minerals and medication. Often, the infusion set isplaced in a free standing arrangement in which gravity forces thesolution into the patient. The rate at which the solution enters thepatient can be roughly controlled by various clamps, such as rollerclamps, which are currently available on the market.

In many applications, it is necessary to precisely control the amount ofsolution which enters the patient. When this is the case, a regulatingdevice, such as an enteral feeding pump, is placed along the infusionset to control the rate at which the solution is fed to the patient. Inapplications where a pump, etc., is used, the clamps used to regulateflow are typically opened to their fullest extent to prevent the clampfrom interfering with the proper functioning of the pump. The clamp isopened with the expectation that the enteral feeding pump will controlfluid flow through the infusion set.

It is not uncommon, however, for emergencies or other distractions toprevent the medical personnel from properly loading the infusion set inthe enteral feeding pump. When the infusion set is not properly loadedin the pump and the clamp has been opened, a situation known asfree-flow often develops. The force of gravity causes the solution toflow freely into the patient unchecked by the pump or other regulatingdevice. Under a free-flow condition, an amount of solution many timesthe desired dose can be supplied to the patient within a relativelyshort time period. This can be particularly dangerous if the solutioncontains potent medicines and/or the patient's body is not physicallystrong enough to adjust to the large inflow of solution.

Numerous devices have been developed in an attempt to prevent free flowconditions. Such devices, however, typically add significantly to theoverall cost of the infusion set and some provide only marginalprotection against free flow.

Thus, there is a need for a device that prevents a free-flow conditionwhile allowing controlled flow through the infusion set. There is also aneed for such a device which prevents free-flow if an infusion set isnot properly mounted in a pump or other regulating means. Furthermore,there is a need for a device which prevents free-flow and which isinexpensive and easy to use.

SUMMARY OF THE INVENTION

It is an object of the present invention to provide an apparatus andmethod for occluding infusion sets to prevent an accidental free-flowcondition.

It is another object of the present invention to provide an occluderwhich is simple to make and use.

It is another object of the present invention to provide such anoccluder which is inexpensive and thus disposable.

It is still another object of the present invention to provide anoccluder which occludes fluid flow through the infusion set unless theinfusion set is properly loaded in a flow control mechanism such as anenteral feeding pump.

It is still yet another object of the present invention to provide suchan occluder which allows for a simple manual override of the occludingfunction.

It is still yet another aspect of the present invention to provide anoccluder which functions as a valve to effectively control fluid flowthrough a flexible conduit.

One or more of the above and other objects of the invention are realizedin an apparatus and method for preventing free flow in an infusion set.In accordance with one aspect of the invention, an occluder is disposedwithin the infusion set. The occluder is configured to prevent free flowof fluids in the infusion set past the occluder. The occluder is alsoconfigured, however, to selectively allow solutions to pass by theoccluder which are pumped by an enteral feeding pump and the like.

In accordance with one embodiment of the invention, the occluder isformed by a stop placed in the tubing of the infusion set. The stoplimits flow through the tube by limiting flow around and/or through thestop when the solution is subject to flow due to gravity. However, whengreater pressures are placed on the solution, such as those produced bya pump, the solution is able to flow around and/or through the stop,thereby delivering the solution to the patient.

In accordance with another embodiment of the present invention, anoccluding valve is disposed in the infusion set. The valve prevents freeflow through the infusion set due to gravity, while allowing controlledflow of solution through the infusion set.

In accordance with another aspect of the invention, the occluder isconfigured to stop fluid flow until the infusion set has been properlyloaded into a control mechanism such as a pump. Once properly placed,the interaction between the occluder and the infusion set effectivelyopens the infusion set to allow solution to flow therethrough.

In accordance with still another aspect of the present invention, theoccluder can be formed integrally with the infusion set or can be formedof independent piece(s) which are then placed in the infusion set toselectively occlude the flow of solution therethrough.

In accordance with still yet another aspect of the invention, theoccluder can function as a valve to selectively allow fluid flowtherethrough. In one embodiment, a pair of occluders and infusion linecan be used in conjunction with a piston or other force applicator toform a linear peristaltic pump which delivers predetermined amounts offluid to a patient.

In accordance with still yet another aspect of the present invention,the occluder and infusion line can be formed to nest in and be opened bya conventional fluid flow pump.

BRIEF DESCRIPTION OF THE DRAWINGS

The above and other objects, features, and advantages of the inventionwill become apparent from a consideration of the following detaileddescription presented in connection with the accompanying drawings inwhich:

FIG. 1 shows an perspective view of an infusion set made in accordancewith the prior art;

FIG. 2A shows a fragmented, side cross-sectional view of an apparatusand method for preventing free-flow through an infusion set in the formof an occluder mounted in an infusion set with the occluder and infusionset in a closed configuration;

FIG. 2B shows a fragmented, side cross-sectional view similar to that ofFIG. 2A, wherein the occluder and infusion set are in an openconfiguration;

FIG. 2C shows a fragmented, side cross-sectional view of an alternateoccluder/infusion set configuration made in accordance with theprinciples of the present invention;

FIG. 3A shows a fragmented, side cross-sectional view of an alternateapparatus and method for preventing free-flow through an infusion set inaccordance with the principles of the present invention;

FIG. 3B shows a fragmented, cross-sectional view of an alternateoccluder embodiment, with the occluder and infusion set being disposedin a closed configuration;

FIG. 3C shows a cross-sectional view of the occluder embodiment of FIG.3A with the occluder and infusion set being disposed in an openconfiguration;

FIG. 3D shows a fragmented, side cross-sectional view of anotherembodiment of an occluder and infusion set made in accordance with theprinciples of the present invention;

FIG. 3E shows a fragmented, side cross-sectional view of still yetanother embodiment of an occluder and infusion set made in accordancewith the principles of the present invention;

FIG. 4A shows fragmented, side cross-sectional view of anotherembodiment of an occluder and infusion set with the occluder in a closedconfiguration;

FIG. 4B shows a cross-sectional view of the embodiment of FIG. 4A in anopen configuration;

FIG. 5A shows a fragmented side cross-sectional view of an occluder andinfusion set made in accordance with one aspect of the present inventionwith the occluder and infusion set being in a closed position;

FIG. 5B shows a cross-sectional view taken along plane 5A—5A of FIG. 5A;

FIG. 5C shows a fragmented, side cross-sectional view of an infusion setwith an occluder disposed therein, with the infusion set being mountedin a control mechanism to maintain the infusion set and occluder in anopen configuration;

FIG. 5D shows a cross-sectional view taken along the plane 5B—5B of FIG.5C;

FIG. 5E shows a perspective view of a housing of a control mechanism asmay be used to hold the infusion set and occluder in an open position asshown in FIG. 5D;

FIG. 6A shows a fragmented, side cross-sectional view of an infusion sethaving an occluder formed therein in accordance with an aspect of thepresent invention;

FIG. 6B shows a view similar to that shown in FIG. 6A with the occluderheld in an open position;

FIG. 7 shows another configuration of an occluder made in accordancewith the principles of the present invention;

FIG. 8 shows yet another configuration of an occluder made in accordancewith the principles of the present invention;

FIG. 8A shows a cross-sectional view of another configuration of anoccluder in accordance with the present invention;

FIG. 8B shows a cross-sectional view of still yet another configurationof an occluder in accordance with the present invention;

FIG. 9 shows yet another aspect of the invention wherein the occluderforms part of a liquid control valve;

FIG. 10 shows a perspective view of a clip for retrofitting existingpumps of use with an occluder of the present invention;

FIG. 11 shows a side cross-sectional view of a pair of occluders andinfusion line which form a pair of valves, and a force applicator toform a linear peristaltic pump;

FIG. 12A shows a front view of an enteral feeding pump of the prior artwith an occluder in accordance with the present invention disposedtherein;

FIG. 12B shows a close-up, cross-sectional view of the occluder,infusion set and a portion of the pump to demonstrate opening of a fluidflow pathway around the occluder;

FIG. 13A shows a side view of an alternate embodiment of an occludermade in accordance with the principles of the present invention;

FIG. 13B shows a cross-sectional view of the occluder embodiment of FIG.13A taken along the line 13A—13A;

FIG. 13C shows an end view of the occluder of FIGS. 13A and 13B;

FIG. 13D shows a top view of an enteral feeding pump having an infusionset disposed therein, with an occluder positioned in the infusion set toprevent free-flow therethrough in accordance with the present invention;

FIG. 13E shows a front view of another available enteral feeding pumphaving an infusion set disposed therein, with an occluder positioned inthe infusion set to prevent free-flow therethrough in accordance withthe present invention;

FIG. 14 shows a perspective view of an alternate embodiment of anoccluder made in accordance with the principles of the presentinvention;

FIG. 14A shows a side view of the occluder of FIG. 14;

FIG. 14B an end view of the occluder of FIG. 14;

FIG. 15 shows a top view of yet another embodiment of an occluder madein accordance with the principles of the present invention;

FIG. 15A and FIG. 15H show cross-sectional views of a portion of aninfusion set with the occluder of FIG. 15 disposed therein;

FIG. 15B shows a top view of a stop of an occluder showing an alternateconfiguration for the stop relative to that shown in FIG. 15;

FIG. 15C shows a top view of an alternate embodiment of an occluderstop;

FIG. 15D shows a top view of another embodiment of an occluder stop;

FIG. 15E shows a top view of yet another occluder stop made inaccordance with the principles of the present invention;

FIG. 15F shows a top view of still another stop of an occluder showingan alternate configuration for the stop relative to that shown in FIGS.15 through 15E;

FIG. 15G shows a top view of still another stop of an occluder inaccordance with the principles of the present invention; and

FIG. 16 shows a fragmented, side cross-sectional view of an infusion setwith an occluder disposed therein and a control mechanism to maintainthe infusion set and occluder in an open configuration.

DETAILED DESCRIPTION

Reference will now be made to the drawings in which the various elementsof the present invention will be given numeral designations and in whichthe invention will be discussed so as to enable one skilled in the artto make and use the invention. It is to be understood that the followingdescription is only exemplary of the principles of the presentinvention, and should not be viewed as narrowing the pending claims.Additionally, while various embodiments will achieve some of theobjectives set forth above, it will be understood that some embodimentsmay not achieve all of the objectives and the objectives should not beviewed as limiting the pending claims.

Referring to FIG. 1, there is shown a perspective view of an infusionset 10 and related structures in accordance with the teachings of theprior art. Disposed at one end 10 a of the infusion set 10 is a bag 14for holding parenteral or enteral solutions. Typically, the bag 14 issupported by a stand 18 which holds the bag approximately 6 feet off thefloor.

The opposing end 10 b of the infusion set 10 is connected to a patient(not shown). In a parenteral use, the end of the infusion set 10 wouldhave a needle attached thereto which extends into the patient's venoussystem. In a enteral use, the end 10 b would typically have a fittingwhich attached to a balloon catheter (not shown) mounted in a stoma inthe patient's stomach. The end may also be connected to a nasoentericfeeding tube.

Solution flows under gravity from the upper end 10 a of the infusion set10 to the lower end 10 b. The pressure on the fluid is 0.433 psi perfoot. Thus, if the bag 14 is disposed five feet higher than the patient,the pressure at the lower end 10 b of the infusion set 10 is about 2.165psi. From the extreme height of 8 feet to the floor, the solution in theinfusion set 10 can reach approximately 3.5 psi.

To control the flow of solution through the infusion set 10, theinfusion set is typically mounted through a flow control portion of apump 22. The pump 22 selectively allows a metered amount of solution topass distally (downstream) from the pump. This can be accomplished inmultiple ways. For example, many enteral feeding pumps are peristalticpumps which have a rotor which engages the infusion set 10 with aplurality rollers. Each partial rotation of the rotor allows apredetermined dose to pass to the patient. By controlling the rate atwhich the rotor turns, the pump can provide highly accurate doses of thesolution.

Other pumps known in the art control solution flow through the infusionset 10 by a plurality of fingers which engage the infusion set. Bycontrolling the position and frequency of the engagement of the fingersagainst the infusion set 10, a highly accurate dose can be provided tothe patient.

While the pump 22 controls the solution flow through the infusion set 10when the infusion set is properly loaded, failure to load the infusionset properly in the pump can quickly result in a free flow condition inwhich the solution flows uncontrolled through the infusion set. Toprevent free flow, a clamp 26 is disposed along the infusion set 10.Typically, the clamp 26 is disposed above the pump 22. One common typeof clamp 26 is a roller clamp which allows some control over thepresence of flow and flow volume through the infusion set 10. Otherclamps simply provide on/off control.

While the infusion set 22 should be mounted in the pump 22 prior to orimmediately after opening the clamp, this is not always done. There aremany situations in a hospital or nursing home setting in which the nurseor physician is called away or otherwise distracted prior to properplacement of the infusion set 10. If the clamp has already been opened,the result is that the solution in the bag 18 flows uncontrolled intothe patient.

In many situations, the free flow of the solution will cause no realthreat to the patient. In some situations, however, free flow can causeserious injury or even death to the patient. For example, a criticallyill patient may suffer severe shock if a large amount of solution wereto suddenly flow into his or her body. Likewise, a patient receivingheavily medicated solution may be seriously injured if a solution thatwas designed to be delivered over a number of hours were delivered in afew minutes.

To resolve such concerns, pinch clips may be disposed on the infusionset 10. The pinch clip automatically closes the infusion set unless itis properly mounted in the infusion set 10. An example of such a pinchclip is disclosed in U.S. Pat. No. 5,810,323.

While pinch clip occluders are a significant advantage over thepossibility of free flow, they are relatively expensive to make. Whilesuch an occluder may only cost ten to twenty cents, using a new occluderwith every infusion set adds a proportionally significant amount to thecost of an infusion set. Thus, there is a need to find an apparatus andmethod for preventing free flow in an infusion set which is reliable andwhich is less expensive than the prior art.

Turning now to FIG. 2A, there is shown a fragmented, cross-sectional ofan infusion set, generally indicated at 100, with a stop or occluder 104disposed therein. The infusion set 100 is formed by an elongate tube 108made of a flexible, resilient material such as silicone rubber, latex ,polyurethane, neoprene or numerous similar medical grade materials. (Inlight of the present disclosure, those skilled in the art willappreciate that the present invention may be used in nonmedical contextsas well. In such situations, the tube may be made of materials which arenot medical grade.)

The occluder 104 has an exterior diameter which is slightly larger thanthe interior diameter of the tube forming the infusion set 100. Thiscauses a portion 108 a of the tube to stretch slightly as is passes overthe occluder 104.

The occluder 104 prevents flow through the infusion set 100 based ongravity. Thus, the size of the occluder 104 will depend on the materialused to form the infusion set. In a presently preferred embodiment, theinfusion set 100 is formed from a tube made of silicone rubber. The tubehas a wall thickness of approximately 0.038 inches and an inner diameterof approximately 0.130 inches. The occluder 104 is preferably formed outof a plastic (e.g. acrylonitrile butyl styrene (ABS), acrylic (PMMA),polycarbonate, etc.) or a stainless steel ball bearing having an outerdiameter of 0.141 inches.

Because the occluder 104 is larger than the interior diameter of theinfusion set 100, solution which is under only the force of gravity willback-up behind the occluder and not pass. To prevent the occluder 104from gradually working its way downstream, a projection 112 can beformed in the infusion set 100 or, as explained in detail below, theoccluder may be fastened to a connector or some other stationarystructure.

Because the infusion set 100 is formed by an elongate, resilient tube108, increases in pressure will cause the interior diameter of the tubeto expand. When the tube 108 expands sufficiently, the portion 108 a ofthe tube which passes over the occluder 104 allows the solution to flowaround the occluder and into the distal part 100 b of the infusion set100 as shown in FIG. 2B.

Preferably, the occluder 104 and infusion set 100 are selected so thatup to 4 psi can be maintained upstream of the occluder, i.e. in theproximal portion of the infusion set, before the portion 108 a of theelongate tube 108 extending over the occluder will expand sufficientlyto allow any clinically significant amount of solution to pass.

While solution hanging in the bag 18 may develop 2 to 3 psi due togravity, it will not have enough pressure to pass by the occluder 104without application of some external force. In contrast, an enteralfeeding pump or other type of pump will typically generate between 5 and15 psi. When the solution is pressurized to 5 to 15 psi by the pump, thesolution is under sufficient pressure to go around the occluder 104 fordelivery to the patient. In other words, if the infusion set 100 is notproperly mounted in the pump so that the pump will generate a higherpressure in the proximal part 100 a of the infusion set, the occluder104 inhibits flow to the patient. Thus, there can be no free flow whileaccommodating flow of solution to the patient when the infusion set 100is properly mounted in the pump.

Turning now to FIG. 2C, there is shown a fragmented, sidecross-sectional view of an alternate configuration of an infusion set,generally indicated at 130, and the occluder 104. As with the previousembodiment, the occluder 130 is formed by a small sphere, typicallyformed of a biologically inert plastic or stainless steel. The infusionset 130 is formed of a first tube 134 and a second tube 138. The firsttube 134 is formed of a resilient polymer or silicone so that the tubemay expand with pressure. The second tube 138 is typically slightlysmaller than the first tube 134 so that the distal end 134 a of thefirst tube can be attached to the exterior of the proximal end 138 a ofthe second tube.

To ensure that the occluder 104 does not advance distally into thesecond tube 138, the second tube 138 is preferably formed from amaterial which is semi-resilient or nonresilient and therefore will notaccommodate advancement of the occluder 104. To prevent the proximal end138 a of the second tube 138 from forming a seal with the occluder 104,the proximal end preferably has one or more indentations 142 or contoursformed therein. The indentations 142 or contours ensure that liquid willbe able to flow around the occluder 104 even if the occluder is pressedfirmly against the proximal end 138 a of the second tube 138.

When pressures less than about 4 psi are disposed proximally from theoccluder 104, the first tube 134 engages the occluder and preventsliquid from flowing down stream. Once the pressure on the proximal sideof the occluder 104 exceeds approximately 4 psi, the distal end 134 a ofthe first tube 134 expands and allows liquid to flow by in the mannerdemonstrated by arrows 146. Once the pressure subsides, the first tube134 returns to its original size and liquid flow terminates until thepressure again is raised above the threshold.

In use, the infusion set 130 and occluder 104 prevent free flow unlessthe infusion set is placed in engagement with a pump that can generatesufficient psi to compel flow around the occluder. Once past theoccluder 104, the pressure of the liquid quickly falls to a conventionallevel and there is no danger to the patient.

Turning now to FIG. 3A, there is shown a fragmented, cross-sectionalview of another embodiment of principle of the present invention. Aninfusion set 160 has a proximal portion 160 a and a distal portion 160b. Disposed between the proximal portion 160 a and the distal portion160 b is an occluder or stop 164. The stop 164 is disposed in theinfusion set 160 to selectively prevent flow from the proximal portion160 a to the distal portion 160 b.

The stop 164 includes a proximal end 164 a and a distal end 164 b.Beginning at the proximal end 164 is a channel 170. As shown in FIG. 3A,the channel has a proximal portion 170 a and two distal portions 170 bwhich are in fluid communication with the proximal portion. While theproximal portion 170 a is disposed in continuous communication with theinterior of the proximal portion 160 a, each of the distal portions 170b of the stop 164 are typically disposed in communication with thesidewall of the infusion set 160. The sidewall of the infusion set 160normally prevents fluid flow out of the distal portions 170 b of thechannel 170.

Preferably, the sidewall will have sufficient resistance to expansionthat a pressure of about 4 psi can be placed in the channel 170 withoutcausing the infusion set 160 to radially distend or expand. Thus, if thepressure in the proximal portion 160 a of the infusion set 160 is belowabout 4 psi, the liquid will not flow through the stop 164.

As shown in FIG. 3A, the stop 164 is relatively long. To maintain itselfin place, the stop 164 frictionally engages the sidewall defining theinfusion set 160. By providing a stop 164 which is long, greater surfacearea is provided to engage the sidewall and prevent the stop 164 frombeing slowly moved downstream.

Turning now to FIG. 3B, there is shown a fragmented, sidecross-sectional view of an infusion set, generally indicated at 180. Theinfusion set 180 includes a proximal (upstream) end 180 a and a distal(downstream) end 180 b which are separated by an occluder or stop 184.The stop 184 is similar to the stop 164 shown in FIG. 3A in that it hasa channel 190 with a proximal portion 190 a and a pair of distalportions 190 b.

Rather than relying on an elongate body and frictional engagement withthe sidewall of the infusion set 180, the stop 184 has at least oneprojection 194 which extends outwardly from the stop to engage thesidewall of the infusion set and prevent advancement. Preferably, theprojection 194 is formed by an annular projection, or a plurality ofspaced projections extending radially outwardly from the stop 184.

Turning now to FIG. 3C, there is shown a cross-sectional view of theinfusion set 180 and stop 184 of FIG. 3B. As the pressure in theproximal portion 180 a of the infusion set 180 increases to greater thanabout 4 psi, the infusion set will distend radially. This allows liquidcontained in the proximal portion 180 a of the infusion set 180 to flowinto the proximal portion 190 a of the channel 190, out the distalportions 190 b of the channel and into the distal portion 180 b of theinfusion set. Once the pressure drops below about 4 psi, the infusionset 180 will retract and the flow in the channel 190 will be terminatedas the sidewall of the infusion set covers the distal portions 190 b ofthe channel 190.

In such a manner, the embodiments shown in FIGS. 3A through 3C preventfree flow by preventing liquid flow under 4 psi. Once the infusion set180 is properly mounted in the pump, the increased pressure created byrotation of the rotor (or other pressure source) overcomes therestriction to flow imposed by the stop 184. When combined with thecontrol provided by the various types of infusion pumps, the occluder orstop 164 or 184 enables a predetermined amount of liquid to flow throughinfusion set 160 or 180 while preventing the dangers of free flowconditions.

FIG. 3D shows a side cross-sectional view of yet another embodiment ofan infusion set, generally indicated at 200, having an occluder or stop204 disposed therein. The infusion set 200 includes a proximal portionformed by a first tube 208 and a distal portion formed by a second tube212. The proximal end 212 a of the second tube 212 is mounted about theexterior of the distal end 208 a of the first tube 208.

Disposed at the distal end 208 a of the first tube 208 and the proximalend 212 a of the second tube 212 is the stop 204. The stop 204 has achannel 216 extending from a proximal end 204 of the stop to a radiallylateral position adjacent the distal end 204 b of the stop. Thus, thechannel is in fluid communication with liquid in the first tube 208, butis normally isolated from the interior of the second tube 212.

When pressures in the first tube exceed about 4 psi, the proximal end212 a of the second tube 212 radially expands, thereby opening thedistal end of the channel 216 and allowing liquid to flow into thedistal portion of the infusion set formed by the second tube 212.

By positioning the stop 204 at the ends of two tube segments, the stopcan be adhesively attached to either of the tubes to prevent distalmovement of the stop. This can be accomplished without interfering withthe ability of the stop to prevent flow below about 4 psi, whileallowing pressures above about 4 psi cause liquid to pass through theinfusion set.

While the embodiments of FIGS. 3A through 3D show embodiments in whichthe proximal end of the channel is in continuous communication with theupstream flow and the distal end of the channel is normally closed, thestop 164, 184 or 204 could be rotated so that the proximal or upstreamportion of the channel is normally closed by the sidewall of theinfusion set 160, 180 or 200 and the distal portion of the channel isalways in communication with the distal portion of the infusion set.

FIG. 3E shows yet another embodiment of an infusion set, generallyindicated at 230, and an occluder 234. The occluder 234 is disposed inthe infusion set 230 so as to divide the infusion set 230 into aproximal, upstream portion 230 a and a distal, downstream portion 230 b.

The occluder 234 has a channel 238 which extends from a proximal end 234a of the occluder to the distal end 238 b so as to form a passagewaythrough which an infusion liquid, such as enteral feeding solution, maypass. A wall 242 is disposed along the channel 238 to selectivelyprevent flow through the channel. In accordance with the principles ofthe present invention, the wall 242 is pivotably attached to theoccluder 234 in such a manner that the wall will not move to allowliquid flow through the channel until the proximal, upstream pressureexceeds 4 psi. (While described as requiring a threshold upstreampressure, in light of the present disclosure those skilled in the artwill appreciate that the wall will move based on a pressure differentialbetween the proximal and distal portions of the infusion set. Thus, thesame effect could be generated by developing a vacuum downstream fromthe occluder 234). Those skilled in the art will appreciate that theabove embodiments could be designed for other thresholds as well.

Once the desired pressure threshold has been reached, the wall 242 willpivot and open the channel 238 to flow. Once the pressure drops, thewall 242 will pivot closed in accordance with one method of use. Inaccordance with another method of use, however, the wall 242 can have ascore 246 formed therein. The wall 242 is designed to remain occludingthe infusion set 230 until the pressure threshold is exceeded. Oncedeflected out of the way, the wall may not return to its originalposition even after the pressure drop. Because the pressure increasenecessary to move the wall 242 is generated by the pump (not shown), theinfusion set 230 must have been properly loaded in the pump for the wallto open. When the infusion set 230 is properly loaded in the pump, thepump will prevent free flow. Thus, if the infusion set 230 is properlyloaded in the pump, the occluder does not need to continue to preventfree flow.

Turning now to FIGS. 4A and 4B, there are shown fragmented, sidecross-sectional views of yet another embodiment of the presentinvention. An infusion set, generally indicated at 250 has an occluder254 in the form of a duckbill valve formed therein to divide theinfusion set 250 into a proximal, upstream portion 250 a and a distal,downstream portion 250 b. The occluder 254 is formed of two vanes 258 aand 258 b which are biased into engagement with one another.

When the pressure in the proximal portion 250 a of the infusion set 250is less than about 4 psi, the biasing of the vanes 258 a and 258 b keepthem in contact as shown in FIG. 4A. Once the pressure in the proximalportion 250 a exceeds about 4 psi, the pressure forces the valves 258 aand 258 b away from each other, thereby allowing an infusion liquid toflow through the occluder 254 and into the distal portion 250 b of theinfusion set 250 as shown in FIG. 4B. In order for the occluder 254 towork in such a manner, it is preferable for the vanes 258 a and 258 b toextend distally as they engage one another. However, the occluder 254could be made so that the vanes extend proximally and then buckle oncethe threshold pressure has been passed.

The occluder 254 is shown as being molded integrally with the infusionset 250. Such a configuration prevents any concern as to whether theoccluder 254 may move during use. However, it is feasible to also formsuch an occluder 254 as a separate unit and then position it within theinfusion set 250. The occluder 254 could be held in place with adhesivesor merely a friction fit.

Turning now to FIG. 5A there is shown a fragmented, side cross-sectionalview of an infusion set, generally indicated at 300, with an occluder304 disposed therein. Similar to the embodiment shown in FIG. 2A, theinfusion set 300 is made of conventional silicone tubing or some otherresilient or semi-resilient material, such as latex, polyurethane, etc.

FIG. 5B shows a cross-sectional view of the infusion set 300 andoccluder 304 taken along the plane A—A in FIG. 5A. As shown, the tubedefining the infusion set 300 forms a seal around the occluder 304 andprevents liquid from passing between the occluder and the tube formingthe infusion set.

Turning now to FIG. 5C, there is shown a side cross-sectional view ofthe infusion set 300 and the occluder 304. Disposed behind the infusionset 300 at the location of the occluder 304 is a wall 308. As will bediscussed in additional detail below, the wall 308, the occluder 304 andthe infusion set 300 form a compression valve for selectively allowingliquid to flow through the infusion set.

FIG. 5D shows a cross-sectional view of the infusion set 300 and theoccluder 304 taken along the plane B—B in FIG. 5C. The infusion set 300and occluder 304 have been mounted between opposing walls 308 which arespaced apart a distance slightly smaller than the outer diameter of theinfusion set. As the infusion set 300 is placed between the opposingwalls 308, the sides of the tubing forming the infusion set arecompressed and held against the occluder 304. This compression alsocauses the top and bottom 300 a and 300 b portions of the tube to extendradially outwardly from the occluder 304, thereby opening a flow path312 above and below the occluder. The flow paths 312 enable liquid inthe infusion set 300 to flow around the occluder 304 and to flow to thepatient.

In the event that the infusion set 300 and occluder 304 are pulled outfrom between the opposing walls 308, the tube forming the infusion set300 will return to the position shown in FIGS. 5A and 5B, therebyterminating flow through the infusion set. Thus, the configuration shownin FIGS. 5A through 5D prevents free flow of infusion liquids throughthe infusion set 300 so long as the infusion set and occluder 304 areproperly mounted between the walls 308 (or some analogous engagementsurfaces). The infusion set 300 and occluder 304 are typicallypositioned between the walls 308 as the infusion set is being loadedinto the pump (not shown). Once properly loaded, the pump controls flowthrough the infusion set 300 and prevents free flow.

Turning now to FIG. 5E, there is shown a perspective view of a housingof an enteral feeding pump, generally indicated at 330, made inaccordance with one aspect of the present invention. The housing 330includes a pair of channels 340 and 344 for holding a portion of aninfusion set tube, such as those discussed with respect to FIGS. 3Athrough 5D. In use, the tube is placed in one channel 340, wrapped abouta motor unit (not shown) which is placed in the opening 350, and thenpositioned in the second channel 344. If a conventional infusion set isnot properly wrapped about the motor unit (or properly installed inother types of pumps) and placed in the channels 340 and 344, afree-flow condition may develop. However, the present invention preventssuch a situation from developing.

As shown in FIG. 5E in broken lines, the infusion set 354 is mounted inthe first and second channels 340 and 344. At least a portion 340 a ofthe channel 340 is sufficiently narrow to form walls, similar to walls308 in FIGS. 5A through 5D, which compress the sides of the tube formingthe infusion set 354, thereby creating a flow path around the occluder(not shown) in the infusion set. If desired, the entire length of thewalls 360 which form the channel 340 could be sufficiently closetogether to compress the infusion set 354 and thereby open flow.

FIG. 5E also shows a cover 370 which is connected to the housing 330.The cover 370 is pivotable with respect to the housing 330 and includesa catch 374 which engages a groove 380 on the housing. When the cover370 is closed and the catch 374 engaged in the groove 380, the infusionset 354 is securely held in the housing 330 and it is unlikely that theinfusion set may be pulled from the pump.

Rather than having the walls 360 of the channel 344 compress the sidesof the infusion set 354 to form a compression valve with the sides ofthe infusion set 354, a projection 384 can be mounted on the cover 370so that it is in alignment with the infusion set. When the cover closes,the projection 384 applies a downward force on the infusion set 354thereby forming an open compression valve with the flow channels beingdisposed in horizontal alignment, rather than vertical alignment asshown in FIG. 5D. Thus, liquid flowing through the infusion set 354passes around the sides of the occluder, as opposed to above and belowthe occluder.

It will be appreciated in light of the present disclosure, that when aprojection is used to engage the occluder, the occluder need not be heldin a channel. Rather, the infusion set 354 must only be engaged ongenerally opposing sides so as to open at least one flow path around theoccluder, or sufficient pressure must be exerted to cause the infusionset to expand and open a flow path.

As long as the catch 374 on the cover 370 engages the groove 380 on thehousing 330, or the projection 384 is maintained in engagement with theinfusion set 354 at the location of the occluder, the compression valvewill remain open. If the cover 370 is opened, the force holding thecompression valve open is gone and the infusion set 354 will retractinto the closed position shown in FIGS. 5A and 5B, thereby preventingfree flow through the infusion set 354.

Turning now to FIGS. 6A and 6B, there is shown yet another embodiment ofthe present invention. The infusion set, generally indicated at 400, hasan occluder 404 disposed therein. The occluder 404 may be molded in theinfusion set 400, or may be constructed separately and inserted.

The occluder 404 is formed by a first vane 408 a and second vane 408 bwhich form a duck-bill valve. The vanes 408 a and 408 b are disposed sothat they extend proximally (i.e. upstream). As shown in FIG. 6A, thevanes 408 a and 408 b normally engage one other to occlude flow from aproximal portion 400 a of the infusion set 400 to a distal portion 400 bof the infusion set.

When pressure is applied to the tubing which forms the infusion set 400,the vanes 408 a and 408 b move away from each other sufficiently toallow fluid flow through the infusion set. Thus, in FIG. 6, acompression valve is formed by sliding the infusion set 400 between twowalls 412 of engagement surfaces so that the vanes 408 a and 408 b areheld apart, or by forcefully engaging the infusion set with a projectionor other structure associated with a door, etc. As long as the infusionset 400 remains between the walls 412, projections, etc., fluid flow isenabled. If the portion of the infusion set 400 which contains theoccluder 404 is pulled from the walls 412 or projections, the occluderwill return to the closed position wherein it prevents free flow.

Preferably, the infusion set 400 and occluder 404 will be used in ahousing, such as that shown in FIG. 5E. When the infusion set 400 ismounted in a channel defined by restricting sidewalls or when a coverwith an aligned projection is closed, flow is enabled through theinfusion set. If the infusion set 400 is pulled out of the housing, theoccluder 404 will automatically close—thereby preventing free flowthrough the infusion set.

The various embodiments disclosed in accordance with the presentinvention provide a marked improvement over clamps and other types ofexternal occluders which are commonly used to control fluid flow. Theseembodiments provide assurance against free flow, are generally easier tohandle and are much more cost effective than the external occluders ofthe prior art.

In addition to being usable with housings and other fixed structureswhich cause the valve to open, the majority of configurations discussedabove can also be manually opened by simply squeezing the infusion setadjacent the occluder to open a pathway around the occluder. Theavailability to manually open the occluder/infusion set is desirable, asit facilitates priming of the infusion set with the liquid beinginfused. Unlike many of the occluders of the prior art however, simplyreleasing the infusion set adjacent the occluder is all that is requiredto terminate flow.

Turning now to FIG. 7, there is shown another configuration of aninfusion set, generally indicated at 400, and an occluder, 404 made inaccordance with the principles of the present invention. The infusionset 400 is formed by an elongate tube 108 made of a flexible, resilientmaterial such as silicone rubber, latex, polyurethane, neoprene ornumerous similar materials. Typically, the elongate tube has an innerdiameter of approximately 0.130 inches.

The occluder 404 has an exterior diameter which is slightly larger thanthe interior diameter of the tube forming the infusion set 400,typically about 0.141 inches. This causes a portion 408 a of the tube tostretch slightly as it passes over the occluder 404.

The occluder 404 prevents flow through the infusion set 400 based ongravity. Thus, the exact size of the occluder 404 will depend on thematerial used to form the infusion set 400. In a presently preferredembodiment, the infusion set 400 is formed from a tube made of siliconerubber, and the occluder 404 is formed from a plastic (e.g.acrylonitrile butyl styrene (ABS), acrylic (PMMA), polycarbonate, etc.)cylinder having an outer diameter of 0.141 inches and a length of about0.282 inches.

Because the occluder 404 is larger than the interior diameter of theinfusion set 400, solution which is under only the force of gravity willback-up behind the occluder and not pass. Once sufficient pressure ispresent—e.g. pressure produced by a pump—the walls of the infusion setwill expand to allow fluid flow past the occluder 400 as discussed withrespect to FIG. 2A, etc.

While the embodiment shown in FIG. 2A is spherical and the embodimentshown in FIG. 7 is cylindrical, those skilled in the art will appreciatethat numerous other embodiments could be used. For example, the dashedline 412 illustrates an occluder which is bullet shaped. Occluders canalso be egg shaped, or any other shape which provides a stop to fluidflow until a predetermined pressure threshold has been reached. It willalso be appreciated that the occluder 404 need not have a consistentdiameter. By having a portion of the occluder 404 extend radially agreater distance than other parts, a portion of the occluder will alwaysengage the wall of the infusion set 400, thereby reducing the ability ofthe occluder to move within the infusion set.

Turning now to FIG. 8, there is shown still another configuration of aninfusion set 420 and occluder 424 made in accordance with the principlesof the present invention. The infusion set 420 is formed from anelongate tube 428 which has a first portion 432 and a second portion 436which are connected together by a connector 440. The occluder 424 isattached to the connector 440 by a tether 442 to prevent the occluderfrom advancing along the second portion 436 of the elongate tube 428.

When sufficient pressure is present in a proximal, upstream portion 428a of the elongate tube 428, the second portion 432 will expandsufficiently to allow fluid flow past the occluder 424 and into thedistal, downstream portion 428 b of the infusion set 420. One advantageof using the connector is that the first portion 428 a of the elongatetube 428 need not be formed of a material which is resilient, or may usea material which does not expand or contract consistently. In otherwords, less expensive tubing materials may be used for most of theinfusion set 420 without interfering with the interaction between theinfusion set and the occluder 424.

While shown in FIG. 8 as being generally spherical, it should beappreciated that, in accordance with the present invention, the occluder424 could be a variety of shapes. Additionally, a single tether 442 or aplurality of tethers could be used to hold the occluder 424 to theconnector 440.

FIG. 8A shows a cross-sectional view of another configuration of aninfusion set 420, and an occluder 444. Unlike the spherical occluder 424of FIG. 8, the occluder 444 of FIG. 8A is disk shaped. To prevent theoccluder 444 from rotating in response to fluid pressure andinadvertently opening a fluid flow path, a plurality of tethers 442 areused to secure the disk to the connector 440.

When pressure in the infusion set 420 is sufficient, the tube 428 willexpand and allow fluid flow past the occluder 444. Once the pressuredrops below a predetermined threshold, the tube 428 will again engagethe occluder 444 and terminate flow.

FIG. 8B shows a cross-sectional view of still yet another configurationof an occluder, 446, made in accordance with the principles of thepresent invention. The infusion set 420 and related portions are thesame as in FIGS. 8 and 8A and are numbered accordingly.

The connector 440 is attached by one or more tethers 442 to the occluder446 to prevent the occluder from moving down stream. The tethers 442 canalso be used to keep the occluder 446 in a desired orientation. Whensufficient pressure is present, the tube 436 expands to allow fluid flowpast the occluder 446.

FIG. 9 shows yet another aspect of the invention wherein the infusionset 450 and occluder 454 forms part of a liquid control valve, generallyindicated at 460. In accordance with the embodiments discussed above,and particularly the discussion surrounding 5A through 5E, the occluder454 normally prevents fluid flow through the infusion set. However,squeezing the infusion set on opposing sides of the infusion setsidewall 450 a caused other portions of the sidewall to extend away fromthe occluder 454—as demonstrated in FIGS. 5C and 5D.

Disposed adjacent to the infusion set 450 and occluder 454 are a pair ofengagement members 464 which are in communication with an actuator 468,such as a motor. The communication can be electronic, mechanical orpneumatic, so long as the actuator 468 is able to control movement ofone or more of the engagement members 464.

When the engagement members are actuated, they apply an inward force tothe infusion set 450 at the location of the occluder 454 to open apassage way around the occluder and thereby enable fluid flow throughthe infusion set. When the engagement members 464 are adjusted to nolonger apply sufficient force to the infusion set 450, the infusion setagain surrounds the occluder 454 and prevents fluid flow.

By selectively actuating the engagement members 464, the infusion set450 and occluder 454, a valve is formed for controlling fluid flow. Byapplying a pressure sensor or other type of sensor, the valve can beused to regulate flow and flow through the valve can be determined.

Turning now to FIG. 10, there is shown a perspective view of a clip,generally indicated at 480, for opening flow between an occluder andinfusion set. Those skilled in the art will appreciate that there are anumber of enteral and parenteral pumps in the market which use varioustypes of occluders which suffer from the problems identified in thebackground section. To eliminate these concerns, the clip 480 isconfigured for retrofitting an existing pump for use with anoccluder/infusion set made in accordance with the principles of thepresent invention. (Of course, with some existing pumps, the occluderand infusion set may be configured to nest in the pump in such a mannerthat retrofitting is not necessary.)

The clip 480 includes a base 484 which is provided for attachment to thehousing of a conventional fluid pump. Typically, the base 484 will havean adhesive disposed thereon. If desired, the adhesive may be selectedfrom removable adhesives, such as those known to those skilled in theart, so that the clip 480 can be removed from the pump when an infusionset containing an occluder (such as that represented by the dashed lines488) is not being used with the pump.

Extending from the base 484 is a fitting 490 having channel 492 formedtherein. The channel 492 is preferably formed with an open end andextends into the clip 480. As the infusion set, represented in shadow at488, is inserted into the channel 492, walls 494 defining the channelcompress the infusion set 488 against the occluder (shown as dashedlines 498) to open a pair of flow channels between the occluder and theinfusion set as shown in FIGS. 5A through 5D.

As long as the infusion set 488 and occluder 498 remain securely heldbetween the walls 494 defining the channel 492, fluid flow is enabledbetween the occluder and the infusion set. If the infusion set 488 ispulled from the channel 492 or is never properly placed in the channel,flow through the infusion set is prevented. Thus, the risk of free flowdeveloping within the system is significantly reduced. Of course, therisk of free flow can virtually be eliminated by placing the clip 480 onthe pump in such a manner that the infusion set 488 must be properlyloaded in the pump in order to fit within the channel 492.

FIG. 11 shows a side cross-sectional view of yet another embodiment ofthe present invention which forms an in-line pump, generally indicatedat 500. As shown in FIG. 11, a pair of occluders 504 and 508 aredisposed in an infusion line 512. Each of the occluders 504 and 508 isdisposed adjacent an actuator 514 and 518, respectively. The actuators514 and 518 are configured to selectively apply pressure to the infusionline 512 to selectively open flow channels between the infusion line andthe occluder 504 or 508 with which each is associated.

In use, liquid in the infusion line 512 will be held in a proximalportion 512 a which is upstream from the first occluder 504. The firstoccluder 504 prevents the liquid from flowing down stream until a drivemechanism 522 causes the first actuator 514 to apply force to theinfusion line 512 adjacent the first occluder. Applying force to theinfusion line 512 causes a channel to open between the first occluder504 and the infusion line, thereby allowing fluid flow into a middleportion 512 b of the infusion line.

Once the middle portion 512 b of the infusion line 512 has had adequatetime to fill with liquid, the actuator 514 is adjusted so that it nolonger applies sufficient force to the infusion line to enable fluidflow around the occluder 504. The liquid in the middle portion 512 b ofthe infusion line 512 is then isolated from the liquid in the proximalportion 512 a.

The liquid in the middle portion 512 b of the infusion line 512 isprevented from flowing distally or downstream by the second occluder 508which defines the distal end of the middle portion. However, once thedrive mechanism 522 is actuated to move the actuator 518 into forcefulcontact with the infusion line 512 adjacent the occluder 508, one ormore channels are formed between the occluder and the infusion line. Thechannel(s) opened by the actuator 518 squeezing the infusion line 512form a flow path allowing the liquid contained in the middle portion 512b to flow into a distal, downstream portion 512 c. Since no occluder orother stop is typically disposed distally from the second occluder 508,the liquid flowing into the distal portion 512 c is delivered to thepatient.

By selectively controlling the application of force by the firstactuator 514 on the infusion line 512 and first occluder 504 and theapplication of force by the second actuator on the infusion line andsecond occluder 508, a valve, generally indicated at 526, is formedwhich permits a predetermined amount of flow to pass with each series ofactuations.

In a more preferred embodiment, the valve also includes a forceapplicator 530, such as a plunger, roller or similar device, disposed incommunication with the middle portion 512 b of the infusion line 512.The force applicator 530 applies a compressive force to the middleportion 512 b of the infusion line 512 to force the liquid contained inthe middle portion 512 b to flow into the distal portion 512 c of theinfusion line 512 and on to the patient. The force applicator 530ensures that liquid will not simply remain in the middle portion 512 bwhen the second actuator 518 causes a flow path to be formed between thesecond occluder 508 and the infusion line 512.

While applying a compressive force to the middle portion 512 b of theinfusion line 512 helps to force the liquid in the middle portion toflow downstream, it also serves to assist flow into the middle portion.Once a compressive force is no longer applied to the middle portion 512b, the resilient material forming the infusion line will attempt toreturn to its original, tubular configuration. By closing the flow pathbetween the second occluder 508 and the infusion line 512 beforereleasing force applicator 530, a vacuum is formed within the middleportion 512 b. Once the actuator 514 opens a flow path between the firstoccluder 504 and the infusion line 512, the vacuum in the middle portion512 b will draw liquid into the middle portion 512 b as the infusionline returns to its original configuration.

In each cycle of the valve 526, the first actuator 514 will open a flowchannel between the first occluder 504 and the infusion line 512 to fillthe middle portion 512 b with liquid. The first actuator 514 will thenallow the flow channel to close. The second actuator 518 will then opena flow channel between the second actuator 508 and the infusion line 512and the force applicator 530 will apply pressure to the infusion lineforming the middle portion 512 b so that the liquid in the middleportion will flow into the distal portion 512 c and to the patient. Thesecond actuator 518 will then allow the flow channel between the secondoccluder 508 and the infusion line 512 to close. The process will thenbe repeated.

By controlling the interior diameter of the infusion line 512, thedistance between the first occluder 504 and the second occluder 508, andthe movement/size of the force applicator 530, one can obtain apredetermined amount of liquid flow with each cycling of the valve 526.By controlling the number of cycles in a predetermined period of time,the operator is able to provide a highly accurate rate of flow for thesolution passing through the valve 526. Furthermore, because a rotor isnot needed to control flow rate, the valve 526 can be used to make anin-line peristaltic pump which is significantly thinner thanconventional peristaltic pumps while maintaining the same accuracy.

While FIG. 11 shows two actuators, those skilled in the art willunderstand, in light of the present invention, that one of the occluderscould be configured to allow fluid flow responsive to force ifconfigured properly to prevent back flow. This could be achieved, forexample, by controlling the size of the occluders.

Turning now to FIG. 12A, there is shown a perspective view of a pump,generally indicated at 600, which is designed to control fluid flowthrough an infusion set, generally indicated at 604, and into thepatient. The pump 600 includes a control panel 608 which has a pluralityof buttons 610 or other devices for controlling the actuation of thepump. The pump 600 operates to deliver a predetermined dose of enteralfeeding solution to a patient by rotation of a rotor 612.

The infusion set 604 is mounted on the pump so that a resilient portion604 a of the infusion set wraps around the rotor 612. Each rotation orpartial rotation of the rotor 612 causes a predetermined amount ofenteral feeding solution to be advanced through the infusion set 604 anddelivered to the patient.

In order to assure that the rotor 604 is providing the proper amount ofenteral feeding solution, a drip chamber 620 is formed along theinfusion set. An optical sensor 624 is disposed in the enteral feedingpump 600 and monitors the drip rate of the solution in the drip chamber624. The drip rate of the solution is used to calculate an actualdelivery rate of the solution.

As with the prior art, a portion 604 b of the infusion set disposeddistally from the rotor 612 is nested in a channel 630 in the pumphousing 600. In accordance with the present invention, the portion 604 bhas an occluder 634 disposed therein. While the prior art simply usedthe channel 630 to hold the infusion set 604 in contact with the rotors,the inclusion of an occluder 634 provides an improved measure of safety.

In the prior art, if either the portion 604 b of the infusion set 604was not properly positioned in the channel 630, a free flow conditioncould develop in which fluid flow through the infusion set would beunchecked by the rotor 612. In the present invention, flow through theinfusion set 604 is not permitted until the portion 604 b with theoccluder 634 is nested in the channel 630. If the portion 604 b of theinfusion set 604 is not properly placed in the channel 630 or is pulledfrom the channel, the occluder 630 will prevent free flow through theinfusion set.

FIG. 12B shows a close-up, cross-sectional view of the portion of thepump 600 having the channel 630 formed therein taken along the line A—A.The channel 630 receives the infusion set 604 in such a manner that itcompresses the tube 642 against the occluder 634. This causes anotherportion of the tube 642 to extend away from the occlude 634 and therebyopen a fluid flow path between the inner wall of the tube and theoccluder.

As shown in FIG. 5D, compressing opposing sides of the infusion set canopen fluid flow channels both above and below the occluder. In FIG. 12B,the tube 642 of the infusion set 604 is pressed against one half of theoccluder 634, thereby forming a single fluid flow channel 646 on theopposing side. If the portion 604 b of the infusion set 604 containingthe occluder 634 is pulled from the channel 630, the infusion set willengage the occluder and prevent fluid flow.

Turning now to FIG. 13A, there is shown a connector having still anotherembodiment of the present invention. The connector 700 is formed by anadaptor body 708 which is used to connect to pieces of tubing together.Most commonly, the adaptor body 708 is used to connect a silicone tubesegment which engaged the pump rotor, to the remaining tubing of aninfusion set (not shown.) Such connectors 700 are used on a variety ofinfusion sets currently in use.

The adaptor body 708 is formed by a proximal section 712, a distalsection 716, and an annular flange 718 which limits the advancement oftubing the proximal and/or distal sections of the adaptor body. Theproximal section 712 usually engages the silicone tubing, while thedistal section 716 engages the remaining tubing of the infusion set.

An arm 720 forming a tether/spacer extends proximally from the proximalportion 712, and holds an occluder 724 a spaced distance from the restof the adaptor 708. Unlike the prior embodiments discussed above, theoccluder 724 is generally tear drop shaped when the adaptor 708 isstanding on end. As shown in FIG. 13 a, the distal end 724 a of theoccluder 724 may be squared off. However, it may also be rounded orotherwise contoured. In light of the embodiments discussed above, thoseskilled in the art will appreciate that a spherical, diamond shape orother shaped occluder could also be used.

Unlike the tether arrangements discussed in previous embodiments, thearm 720 holds the occluder 724 generally rigidly and proximally from theadaptor. In the event the arm 720 were to be broken by improper bendingof the infusion set in which the adaptor body 708 is mounted, theoccluder 724 would not be able to move down stream in the infusion set.To the contrary, adaptor body 708 would prevent distal movement and theposition of the arm and the shape of the occluder 724 would prevent theoccluder from completely blocking flow through the tube so long as thedesignated pressures are being used to properly expand the tube.

Turning now to FIG. 13B, there is shown a cross-sectional view of theconnector 700 shown in FIG. 13A. This view demonstrates the two flowchannels 730 which are formed on either side of the arm 720. The twoflow channels 730 are configured to allow fluid which had flowed passedthe occluder 724 to enter the hollow channel 734 of the adaptor body 708and to flow downstream from the occluder. An end view of the connector700 is shown in FIG. 13C.

The opening in the proximal end of the proximal section 712 ispreferably about 0.098 inches in diameter and is bisected by the arm 720which is about 0.03 inches thick. The occluder 724 is preferably spacedabout 0.085 inches from the proximal section 712, and is provided with aradius of curvature of 0.025 inches on the front end. The roundedportion of the distal end is typically about 0.03 inches long.

The spacing of the occluder 724 from the proximal section 712 and thesize of the flow channels 730 are sufficient to allow fluid to flowreadily through the connector 700 if the pressure is above about 5 psi.If the pressures are below about 5 psi, the occluder 724 will preventflow of the fluid through the connector 700.

Having the occluder 724 be formed as part of the connector 700 hasseveral distinct advantages. First, it has been found that the occluder724 can be formed by molds substantially the same as the molds currentlyused for such parts. Thus, rather than having to engineer an entirelynew product, infusion set manufacturers can readily adapt their molds toadd the occluder 724. The cost of adapting the mold is almostnegligible. Additionally, the amount of additional plastic used to formthe occluder raises the cost of producing the connector 700 by a merefraction of a cent. This is in contrast to presently available pinchclip occluders and clamps which can cost ten to twenty cents andconstitute more than ten percent of the cost of the infusion set. Thus,for almost no cost, the infusion set can be provided with a highlyreliable anti-free flow device.

FIGS. 13D and 13E shown the pumps discussed in FIGS. 5E and 12A,respectively. To avoid excessive repetition, the pumps are portions ofthe pumps which are similar to those drawings are labeled according.

As shown in FIGS. 13D and 13E, the connector 700 is preferably mountedto the infusion pump downstream from the pump rotor 750 (FIG. 13D) and760 (FIG. 13E). As the pump rotor 750/760 rotates, it will createsufficient pressure to cause the fluid being pumped to pass around theoccluder 724 and into the channel 734 (FIG. 13B) in the connector 700.The fluid is then free to flow down stream.

The connector 700 is highly advantageous because it can be used on mostinfusion pumps without the need for retrofitting or otherwise modifyingthe infusion set. It eliminates the need to recess an occluder as shownat numeral 630/634 in the pump shown in FIG. 12A, and eliminates theneed for modified channels 340/340 a or a projection 384 as discussedwith respect to FIG. 5A. When mounted in the infusion set, the connector700 appears substantially the same as the conventional connector and thepatient may not even know it is being used unless told. However, theadvantages of conventional pinch clip occluders, etc., are achievedwithout the disadvantages.

Turning now to FIGS. 14 to 14B, there is shown an alternate embodimentof a connector or adaptor, generally indicated at 770, made inaccordance with the principles of the present invention. The connector770 is typically formed by an adaptor body 774 which is used to connecttwo pieces of tubing together. However, it will be appreciated in lightof the present disclosure that such a structure is not required. Mostcommonly, the adaptor body 774 is used to connect a silicone tubesegment which engaged the pump rotor, to the remaining tubing of aninfusion set (not shown.)

The adaptor body 774 is formed by a proximal section 778, a distalsection 780, and an annular flange 782 which limits the advancement oftubing the proximal and/or distal sections of the adaptor body. Theproximal section 778 usually engages the silicone tubing, while thedistal section 780 engages the remaining tubing of the infusion set.

Rather that being connected by a tether/spacer as shown in FIGS. 13A and13B which extends into the interior of the proximal section 778, thetether/spacer 784 forms a pair of arms which connect the occluder orstop 788 to the adaptor body 774. It has been found that using a pair ofarms as the tether/spacer 784 decreases the risk of an obstructionpreventing flow through the adaptor body 774. Because the arms 784 arenot disposed in alignment with a hollow channel 790 in the adaptor body,greater unobstructed area is available for moving enteral feedingsolution through the adaptor. This is especially true if the feedingsolution is somewhat viscous. The arms forming the tether/spacer 784 arealso advantageous in that they securely hold the occluder or stop awayfrom the adaptor body 774 in a generally rigid manner and reduce therisk that the stop or occluder 788 will be broken off from the adaptorbody.

By matching the occluder 788 with an appropriately sized infusion settube, a valve can be formed which will open the valve to the flow ofliquid once a predetermined pressure threshold has been reached, butgenerally prevent free flow when the pressure falls below thepredetermined threshold. Those skilled in the art will appreciate thatthe pressure threshold at which the seal between the tubing and theoccluder 788 will crack is a function of the relative sizes of both,along with the elasticity of the tubing.

FIG. 15 shows a top view of yet another embodiment of an in-lineoccluder, generally indicated at 800, made in accordance with theprinciples of the present invention. FIG. 15A shows the occluderdisposed in a tube 808 of an infusion set. The configuration is referredto generally as an in-line occluder simply to illustrate that theconfigurations shown herein can be used in conjunction with two tubes asan adaptor, or can be inserted into a single tube. It is presentlypreferred that the in-line occluder be used as an adaptor for connectingtubing segments. However, it should be appreciated that such is not arequirement and the in-line occluder 800 can be disposed completelywithin a single tube.

The in-line occluder 800 includes a body 804 configured to nest in atube of an infusion set. To this end, the body 804 may include agenerally cylindrical distal portion 804 a and a tapered proximalportion 804 b. The tapered portion 804 b assists in the insertion of thebody into the tube.

Attached to the distal portion 804 a is a flange 812 which can be usedfor securing the position of the occluder 800 in an enteral feedingpump. If the body 804 were desired to be disposed completely in a tube,the flange 812 could be omitted.

Attached to the proximal portion 804 a by one or more arms 816 is anoccluder or stop 820. As with the previous embodiment, it is preferredto have two arms which connect the proximal portion or stop withoutextending into a hollow portion or channel of the body 810 to therebyminimize interference with fluid flow.

One concern which has been raised with having a broadly rounded portionof the occluder or stop 820 which engages the tubing of an infusion setis that the friction between the stop 820 and the tubing can prevent thetubing from resealing against the stop after it has been activated toform a flow channel around the stop. If a seal is not maintained, a freeflow condition could result.

In accordance with one aspect of the present invention, it has beenfound that an improved seal can be achieved by not using broadly roundedstops. More specifically, it has been found that providing the stop 820with an annular detent or channel 824 in a sealing portion 828 providesan improved seal and virtually eliminates the risk of leakage.Furthermore, it is preferred that the channel 824 is defined byrelatively sharp edges 830. Thus, for example, the edges can have aradius of about 0.003 inches, plus or minus 0.002. The sloped walls atthe proximal portion of the stop 820 are preferably disposed at an anglebetween about 60 and 70 degrees, and the back of the stop is preferablybeveled at about 120 degrees. With the overall width being about 0.155inches, the stop 820 forms a highly effective occluder in an infusionset tube.

Ironically, the relatively sharp edges and the channel 824 improvesealing by decreasing the amount of surface area over which the tubingand the stop 820 engage each other. The reduction in surface areaminimizes the amount of friction for the tubing 808 to move from an openposition back into a closed position once it is no longer being pinchedor once the pressure in the tubing drops below the predeterminedthreshold. Effectively, the channel 824 allows the tubing to collapsemore and to thereby form a better seal.

The channel 824 need not be large. To the contrary, a channel which is30–40/1000 ths of an inch deep and 30/1000 ths to about 500/1000 thswork significantly better than a prior art configuration with a broadlyrounded stop of course, the remainder of the stop 820 can be any desiredshape. Thus, as shown in FIGS. 15 and 15A, the stop 820 has a bluntedproximal end.

Turning now to FIG. 15B, there is shown an alternate embodiment of anoccluder or stop 834. The stop 834 will typically be attached to a body,which will not be discussed here. The stop includes a sealing portion838 which is configured to seal against the tubing of an infusion set,etc. The sealing portion 838 in FIG. 15B is different than that shown inFIGS. 15 and 15A in that it provides a pair of bevels 840 in the sealingportion 838 of the stop. The bevels 840 help to form seals with aninfusion tube by reducing friction and minimizing engaged surface area.

FIG. 15C shows an alternate embodiment of an occluder, generallyindicated at 850, made in accordance with the principles of the presentinvention. The occluder 850 includes a stop 854 The stop 854 includesbroadly rounded sides 858 disposed along the sealing portion 862. Tofacilitate sealing between the stop 854 and the tubing, one or more ribs866 are disposed on the stop 854. The ribs 866 extend outwardly so thatengagement of the ribs and the tubing of the infusion set encourages thetubing to flatten out in the sealing area 862 and form a seal with theribs. Again, the reduced surface area of the ribs 866 which is engagedby the tubing helps to minimize friction and allow the tubing to quicklyreseal in the event that it is not being pinched open or forced open dueto the pressure in the tubing.

Turning now to FIG. 15D, there is shown a fragmented view of anoccluder, generally indicated at 870, which forms a stop 874. Disposedon the stop 874 in the sealing area 882 are a pair of annular ribs orrings 886. Unlike the ribs 866 shown in FIG. 15C, the ribs 886 of FIG.15D do not extend radially outwardly to the same extent. Thus, aproximal rib 886 a does not extend out as far as the distal rib 886 b.Those skilled in the art will appreciate that with the ribs present, theunderlying shape of the stop 870 becomes less important, as the ribshelp form the sealing with the tubing while minimizing friction.

FIG. 15E shows still another occluder, generally indicated at 900 whichincludes a stop 904 having a first rib or ring 908 and a second ring 912in the sealing area 916. While the ribs 908 and 912 extend generallyradially to the same extent, they are different than the embodimentshown in FIG. 15C in that they are positioned close together. It will beappreciated in light of the present disclosure that the most desirabledistance between ribs will be a function both of the curvature, if anyof the exterior of the ribs, along with the relative elasticity,flexibility and friction of the tubing.

While the ribs 908 and 912 are relatively thin, broader ribs, such asribs 930 and 934 used on the stop 938 shown in FIG. 15F. Thus, it willbe appreciated that numerous different stop formations can be used tomore securely effectuate sealing of the tubing to prevent free flow.

FIG. 15G shows yet another embodiment of the stop, indicated at 950. Thestop 950 includes an inner portion 954 which is shaped with aconfiguration generally similar to the shape shown in FIG. 13A. An outerlayer 958 is disposed on the inner portion 954 to thereby increase itsdiameter. The outer layer may be formed with ABS and solvent, or in avariety of other ways known to those of skill in the art.

While shown in FIG. 15G as covering the entire inner portion, thoseskilled in the art will appreciate that the stop 950 could be dippedonce or repeatedly into a ABS solution to provide a variety of differentshapes. Thus, for example, the inner layer could be covered half way tothereby form a sealing rib about the inner portion at a desiredlocation. The stop 950 could be dipped repeatedly to form multiplesealing ribs, etc.

Turning now to FIG. 16 there is shown a fragmented, side cross-sectionalview of an infusion set with an occluder disposed therein. While FIGS.5C–D and 9–11 above discuss embodiments wherein flow through theinfusion set is enabled by compressing opposing sides of the tubeagainst the occluder, it has been found in accordance with the presentinvention that a preferred configuration involves compressing the tubefrom generally one side to open a single fluid passage between theoccluder and the tubing. Thus, as shown in FIG. 16, an occluder 960 isdisposed in a tube 964. An actuator 968 is disposed to forcefully engagethe tube 964 to open a fluid flow path 972 past the occluder.

The actuator 968 is configured to press on one side of the occluder, butnot on both sides as discussed in the previous embodiments. The actuator968 preferable has two engagement surfaces 976 and 980. The twoengagement surfaces 976 and 980 are preferably spaced apart at an angleof less than 150 degrees, more preferably between about 90 and 135degrees, and ideally about 110 degrees.

Because the engagement surfaces 976 and 980 of the actuator are offsetbut not opposite one another, the have a tendency to force the tubing insuch a way that a single fluid flow channel 972 is formed passed theoccluder 960. A single fluid flow channel 972 provides for more area andis less likely to be occluded by a viscous solution or a fibroussolution. When combined with the occluder configurations of FIGS. 14 and15, the risk that the occluder will increase the risk of occlusion issignificantly reduced. Furthermore, only requiring the movement of asingle actuator decreases the complexity and cost of an enteral feedingpump.

Thus, there is disclosed an improved apparatus and method for preventingfree flow in an infusion line. The apparatus and method can be used withinfusion control pumps, such as enteral feeding pumps or IV pumps, or asa replacement for such pumps. While the present disclosure disclosesembodiments which are currently preferred, those skilled in the art willappreciate numerous modifications which can be made without departingfrom the scope and spirit of the present invention. For example, therelative size of the infusion set and occluder could be changed byproviding an occluder which shrinks sufficiently under pressure tocreate fluid flow passages. The appended claims are intended to coversuch modifications.

1. An occluder for use in an infusion set, the occluder comprising: abody having a proximal section configured for disposition in a piece oftubing of an infusion set; a stop configured for positioning within thetubing of the infusion set; wherein fluid flow is accomplished by radialexpansion of the tubing from fluid pressure in at least one portion ofthe tubing to enable flow around the stop; wherein the body has achannel therethrough for passing fluid and wherein the stop is attachedto the body by at least one arm, the arm being disposed out of alignmentwith the channel; and wherein the at least one arm comprises a pair ofarms spaced apart from each other and disposed generally opposite oneanother wherein the stop includes an inner portion and an outer layerattached to the inner portion.
 2. An occluder for preventing fluid flowthrough a tube, the occluder comprising: a stop configured for disposalin the tubing, the stop comprising a sealing portion for engaging thetubing to prevent fluid flow between the stop and tubing until thetubing expands radially, wherein the sealing portion further comprisesat least one projection extending from the sealing portion for sealingagainst the tubing; and a body having a channel formed therein forpassing fluid therethrough, the body being attached to the stop by atleast one arm disposed out of alignment with the channel in the body. 3.The occluder according to claim 2, wherein the sealing portion comprisesa generally annular channel.
 4. The occluder according to claim 2,wherein the sealing portion comprises at least one projection forsealing against the tubing which has a rounded shape.
 5. The occluderaccording to claim 2, wherein the at least one projection comprises atleast one annular bevel.
 6. The occluder according to claim 2, whereinthe at least one projection comprises a pair of spaced apart annularbevels.
 7. The occluder according to claim 2, wherein the at least oneprojection comprises at least one annular rib.
 8. The occluder accordingto claim 2, wherein the at least one projection comprises a pair ofspaced apart annular ribs.
 9. An occluder for use in an infusion set,the occluder comprising: a body having a proximal section configured fordisposition in a piece of tubing of an infusion set; a stop configuredfor positioning within the tubing of the infusion set, the stop havingat least one generally annular rib disposed thereon configured forengaging the piece of tubing to form a seal; and wherein fluid flow isaccomplished by radial expansion of the tubing from fluid pressure in atleast one portion of the tubing to enable flow past the stop and betweenthe generally annular rib and the tubing.
 10. The occluder according toclaim 9, wherein the at least one generally annular rib comprises anannular bevel.
 11. The occluder according to claim 10, wherein the atleast one generally annular rib comprises a pair of bevels.
 12. Theoccluder according to claim 11, wherein the bevels are separated by agenerally annular channel.
 13. The occluder according to claim 9,further comprising a first generally annular rib and a second generallyannular rib.
 14. The occluder according to claim 13, wherein the firstgenerally annular rib and the second generally annular rib are spacedapart.
 15. The occluder according to claim 13, wherein the firstgenerally annular rib and the second generally annular rib extendradially outwardly to different degrees.
 16. The occluder according toclaim 13, wherein the first generally annular rib and the secondgenerally annular rib extend radially outwardly substantially to thesame extent.
 17. An occluder for use in an infusion set, the occludercomprising: a body having a proximal section configured for dispositionin a piece of tubing of an infusion set; a stop configured forpositioning within the tubing of the infusion set, the stop having atleast one generally annular rib disposed thereon configured for engagingthe piece of tubing to form a seal; wherein fluid flow is accomplishedby radial expansion of the tubing from fluid pressure in at least oneportion of the tubing to enable flow between the generally annular riband the tubing; and wherein the body has a channel therethrough forpassing fluid and wherein the stop is attached to the body by at leastone arm, the arm being disposed out of alignment with a channel throughthe body.
 18. The occluder according to claim 17, wherein the at leastone generally annular rib comprises two generally annular ribs.
 19. Theoccluder according to claim 18, wherein the two generally annular ribsdefine a channel therebetween.
 20. The occluder according to claim 17,wherein the portion of the stop proximal of the generally annular rib istapered.
 21. The occluder according to claim 17, wherein the proximalend of the stop defines a substantially planar surface disposesgenerally perpendicular to the long axis of the occluder.